510(k) Report

Devices descending from K221921

5 later devices reach DTX Studio Clinic 3.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231898DTX Studio Clinic (4.0)Nobel Biocare AB20231—
+1K231678Overjet Periapical Radiolucency AssistOverjet, Inc.20232—
+2K252934DiagnocatDgnct, LLC20260—
+2K252086DTX Studio AssistNobel Biocare C/O Medicim NV20250—
+2K242600Second Opinion Periapical Radiolucency ContoursPearl, Inc.20250—